World-Class Diagnostics Lab Going Places with “Lab on a Stick”
November 7, 2014
Physicians rely on biomarker detection for diagnoses and treatment decisions. However, the most sensitive and flexible testing tools require dedicated laboratories operated by highly trained personnel, incurring substantial costs and delays in acting upon test results. The ability to implement tests and analyze results at the point-of-care (POC) has been shown to lead to faster treatment decisions, improved access to care, and, ultimately, better outcomes for patients. Current POC methods for biomarker detection are limited by their sensitivity, their ability to detect multiple biomarkers at once, and their lack of flexibility across multiple sample types.The NanoLab platform has the potential to revolutionize diagnostic and treatment procedures by packaging world-class protein detection capabilities into an affordable, self-contained, ultra-portable device that is the size of a handheld calculator. Key features of the device include:
- Greater than 10 times the sensitivity of lab tests using ELISA (current gold standard)
- Uses magnetic nanotags to detect the presence and concentration of proteins
- 15-minute test time (versus 2-3 hour ELISA)
- 64 individual sensors for multiplex capabilities
- Low cost, easy-to-use design
These features allow for the simultaneous, rapid diagnosis of a wide range of conditions. The device includes a reusable station and disposable test sticks that can detect markers for many diseases, from infectious diseases such as HCV, RSV and influenza, to oncology and cardiology. It even has the potential to track short term, mid-term and long-term glucose control in diabetes patients.
The NanoLab hand-held device can perform simultaneous analyses on substantially more analytes, requires only 5 watts of power from a rechargeable battery, and uses a wash-free assay system. These improvements over existing diagnostic systems allow the device to be: 1) truly portable and 2) able to be used even by untrained laymen in non-laboratory settings.
NanoLab’s combination of a wash-free assay with a magnetic biosensor platform is novel, innovative, and patentable. The inventors filed a provisional US patent application for a wash-free analyte detection assay with Stanford University in April 2009. Stanford University filed a US utility patent application and an international patent application in April 2010.
The Bill & Melinda Gates Foundation awarded NanoLab a grant of $100,000 based on the tremendous potential of the platform to improve POC diagnosis in the developing world. In addition, the inventors were awarded first place at the IEEE Change the World competition, first place at Stanford’s eChallenge Business Plan Competition and second place at Wharton’s Business Plan Competition.
The market for POC diagnostic products used in infectious diseases is expected to exceed $1.8 billion by 2017. A significant growth area is hepatitis C (HCV) testing, following the Centers for Disease Control and Prevention’s (CDC) recent call for all adults born between 1945 and 1965 (the entire baby boomer population) to get tested for HCV at least once. The NanoLab platform would provide significant improvement over existing technology, as the current two-step testing protocol results in as many as 50% of people being lost to follow-up between the initial antibody screening test and the second viral load test to determine current infection. The NanoLab platform can, in one simple step and within just a few minutes, identify people who were previously infected with HCV, as well as those who remain actively infected with live virus.
Respiratory syncytial virus (RSV) is a common virus that infects the lungs and breathing passages. While most healthy people recover from RSV infection in 1 to 2 weeks, it can be severe, causing more than 125,000 hospitalizations in children under 4 each year. It is also an important cause of respiratory illness such as pneumonia in older adults. For at risk children and adults, knowing whether an upper respiratory infection is caused by RSV or another virus early in the course of the disease has the potential to improve outcomes as patients can receive palivizumab, a drug that can help prevent severe disease and hospitalization. Rapid assay testing for RSV exists, but it takes about 30 minutes with 90% accuracy depending upon viral collection method (nasal wash being the most accurate). The NanoLab platform has the potential to decrease this time by half, with equivalent or better accuracy, regardless of how the respiratory sample is collected.
The market for POC cardiac marker detection is expected to reach $1.2 billion by 2014 which represents a 14% compound annual growth rate since 2007. POC testing of cardiac markers enables efficient triage of cardiac patients in emergency rooms, ambulances, the field, and ambulatory care centers. Faster diagnosis of an acute myocardial infarction (AMI) has been shown to substantially improve patient outcomes and reduce permanent injury to patients’ hearts within the precious first few hours. NanoLab’s superior sensitivity, fast detection time, ease-of-use, and low cost make it an attractive solution for this market.
- Richard Gaster: Currently a resident physician-scientist at Harvard Medical School; Received his M.D. and Ph.D. in Bioengineering from Stanford University; NanoLab inventor; NSF grant recipient; holder of 7 utility and 3 provisional patents
- Drew Hall: Currently on the faculty at UCSD in the department of Electrical Engineering; Holds a Ph.D. in Electrical Engineering from Stanford University; NanoLab inventor; expertise in analog electronics and GMR biosensors; holder of 1 utility and 1 provisional patent
Here are just a small selection of articles run in the media about our technology
The technology behind NanoLab and the device itself have been featured in a number of scholarly publications, including:
- Lab Chip: “nanoLAB: An ultraportable, handheld diagnostic laboratory for global health”
- Nature Medicine: “Matrix-intensive protein arrays push the limits of biosensors in medicine”
- Nano Letters: “Autoassembly Protein Arrays for Analyzing Antibody Cross-Reactivity”
- Biosens. Bioelectron: “GMR biosensor arrays: A system perspective”; “GMR biosensor arrays: Correction techniques for reproducibility and enhanced sensitivity”
- PNAS: “Multiplex protein assays based on real-time magnetic nanotag sensing”
For further information about this exciting new technology, please contact:
Osiris Biomedical, LLC